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FDA Refuses to Accept Adventrx Pharma’s New Drug Application

Adventrx Pharmaceuticals (NYSE Amex: ANX), the San Diego biotech that sprang back to life in January with a new drug application, says in a statement today that it has received a “refuse to file letter” from the FDA—which basically means it’s back to the drawing board.

Adventrx cut its workforce to just two employees almost a year ago, after its development of a co-factor drug for treating metastatic colorectal cancer failed. Brian Culley, who is now the company’s CEO, told me the biotech then made a “bet the company” decision to restart its development of ANX-530, a formulation of the chemotherapy drug vinorelbine (Navelbine). Much of the drug development work already had been done, and Culley told me Adventrx merely needed to show the FDA it could maintain tight manufacturing controls. When Adventrx announced in January it had filed a new drug application for ANX-530, investors rushed enthusiastically to buy shares in the penny stock.

Once a new drug application is filed, however, the FDA has 60 days to preliminarily review the submission and assess whether the NDA is sufficiently complete to permit a substantive review. The agency issues a refuse to file letter to the applicant if it determines that the application is not sufficiently complete.

Adventrx says in its statement that the FDA letter focuses on the company’s intended commercial manufacturing site. The FDA says the biotech’s application does not include enough information to show the plant can produce the drug in a way that meets drug expiration date requirements. In its statement, Adventrx says, the “FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.”